VIAGRA
registered trademark
Pfizer Pharmaceuticals
For erectile dysfunction
The New Yorker calls it
"the $10 boner pill."
April 27, 1998: as more and more
men with money
try the stuff
Pfizer stock
keeps going up and up.
TODAY
the market dropped
like a stone,
over 120 points while Pfizer
stock goes up 2 more points to 118,
defying gravity like
YOU KNOW WHAT!
Pompeiian
sidewalk sign
THE PACKAGE INSERT
FOR VIAGRA
IS BRIEF AND COMPREHENSIBLE
The package insert which comes with all patented medicines is the same as the text in the Physician's Desk Reference (PDR) and, increasingly, the small print on the reverse side of advertisements - not only in doctors' journals, but in periodicals such as Newsweek.
The package insert is a stylized statement written by manufacturer and approved by the Food and Drug Administration (FDA) and which, in an era of proliferating powerful drugs*, it behooves us to read.
I do it every day and it isn't easy. The print is small and the detail exhaustive but I read with the following grains of salt:
the PDR is produced by the drug companies
the studies cited are mostly "in house," i.e. unpublished and private
drugs, however well tested, are recalled all the time - even good ones such as the anti-convulsant Felbatol. Unless you have a brand new disease (unlikely) you don't need a brand new drug. So, for myself and my patients I follow the maxim: "be not the first by whom the new is tried, nor yet the last to lay the old aside."
Night and day,
this proud fellow
stood guard at the entrance City of Refuge
National Park
on the island of Hawaii as of 1986.
I don't know if his pride's been Bowdlerized or Budgeted, but I hope not.
Viagra according to the package insert, is Sildenafil Citrate, a selective inhibitor of Phosphodiesterase 5 (PDE5) which amplifies the effects of nitric oxide and other nitrates on cyclic Guanosine Mono Phosphate (cGMP) leading to smooth muscle relaxation (dilation of blood vessels supplying the penis mostly, but also the heart and other blood vessels (higher doses cause facial flushing) causing blood to flow into the corpus cavernosum of the penis.
"Sidenafil at recommended doses has no effect in the absence of sexual stimulation."
Nitrates cause headaches, open blood vessels in the heart and have been used for years legally to treat angina pectoris and illegally as "poppers" (amyl nitrate) for better erections. An enzyme inhibitor is one step removed from the nitrates themselves and could have unanticipated effects on other systems.
The PACKAGE INSERT for VIAGRA stood out as follows:
mechanism of action unusually clear
list of adverse reactions short
one weird side effect - on vision! At high doses over days to weeks 3% reported as visual disturbances, described as color tinge or light sensitivity, compared to no such findings in placebo treated patients."
no bold black warning boxes (yet)
remarkable efficacy: 2:1 against placebo in two categories: erections SUFFICIENT for penetration and PERSISTENT after. Placebo did OK too - 24% improvement but the big blue 100 mg rated 82% in 380 men, beating placebo 3:1!
"In eight double blind placebo controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexualstimulation resulted in improved erections, as assessed by penile plethysmography, generally increased with increasing sildenafil dose and plasma concentration. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours."
downside potential limited - it's even possible it protects AGAINST heart attacks during sex.
I'm no party poop and Viagra may be the first real thing in human history - an "aphrodisiac" (for men and still requiring stimulation) - but while nitrates protect the heart they can cause headaches. Don't panic.
are usually migraines, benign but frightening headaches which may coincide with the autonomic fluxes of orgasm. This is the rule. Unfortunately, aneurysms have definitely rutpured during sex with up to 50% instant death and no warning at all. This is hardest on the partner.
Men or women with first degree relatives or strong pedigrees for aneurysms have an estimated 10% chance of having one. Such individuals might choose to undergo Magnetic Resonance Angiography (MRA) as the safest way to rule out a big aneurysm. Any aneurysm carries a 5% chance per year of spontaneously rupturing.
*Adverse Drug Reactions in Hospitalized Patients...[Abstract, Apr 15 JAMA. 1998;279:1200-1205]
. 
more to come
